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A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to characterize cardiac safety of Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: daratumumab + immediate VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic amyloid light chain (AL) amyloidosis with cardiac involvement and to identify potential mitigation strategies for cardiac toxicity (cohort 1); to characterize the pharmacokinetics of subcutaneous (SC) daratumumab, among racial and ethnic minorities, including Black or African American, with newly diagnosed AL amyloidosis treated with D-VCd (cohort 2).
Official title: A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
151
Start Date
2022-03-01
Completion Date
2027-03-02
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
Daratumumab
Daratumumab will be administered subcutaneously.
Cyclophosphamide
Cyclophosphamide will be administered either orally or IV.
Bortezomib
Bortezomib will be administered by SC injection or IV.
Dexamethasone
Dexamethasone will be administered orally or IV.
Locations (46)
City of Hope
Duarte, California, United States
Smilow Cancer Hospital/Yale Cancer Center
New Haven, Connecticut, United States
Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute Emory University
Atlanta, Georgia, United States
Tufts Medical Center
Boston, Massachusetts, United States
Boston University Medical Center
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Memorial Sloan Kettering
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Wake Forest University - Baptist Medical Center
Winston-Salem, North Carolina, United States
University Hospital of Cleveland
Cleveland, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
VCU Medical Center
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
Tom Baker Cancer Center
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
University Health Network UHN Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Peking University First Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
West China Hospital Si Chuan University
Chengdu, China
First affiliated Hospital of Zhejiang University
Hangzhou, China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, China
CHU de Limoges
Limoges, France
Centre hospitalier Lyon-Sud
Pierre-Bénite, France
CHU De Poitiers
Poitiers, France
CHU Rangueil
Toulouse, France
Charite Campus Benjamin Franklin
Berlin, Germany
Universitatsklinikum Essen
Essen, Germany
Universitaetsklinikum Heidelberg Medizinische Klinik V
Heidelberg, Germany
Alexandra General Hospital of Athens
Athens, Greece
Università Degli Studi Di Napoli Federico Ii
Naples, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''
Roma, Italy
University Medical Center Groningen
Groningen, Netherlands
Hospital Maastricht University Medical Center
Maastricht, Netherlands
UMC Utrecht
Utrecht, Netherlands
Hosp. Univ. Germans Trias I Pujol
Badalona, Spain
Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp Clinic de Barcelona
Barcelona, Spain
Clinica Univ. de Navarra
Madrid, Spain
Clinica Univ. de Navarra
Pamplona, Spain
Hosp Clinico Univ de Salamanca
Salamanca, Spain
Leicester Royal Infirmary - Haematology
Leicester, United Kingdom
University College Hospital
London, United Kingdom